Endoscopic devices and related methods of use

ABSTRACT

Embodiments of the invention include a medical device including a handle portion, an end effector assembly, an elongate member connecting the handle portion and the end effector assembly, and one or more treatment devices extendable through the elongate member and end effector assembly. The end effector assembly includes an electrode assembly configured to cauterize tissue. The treatment devices may include an elongate cutting member with a safety tip. The treatment devices may include a multi-lumen catheter with a lumen configured to deliver fluid and another lumen configured to accommodate an injection needle, a cutting member, or other therapeutic or diagnostic devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefits of priority under 35 U.S.C. §§119(e), 120 to U.S. Provisional Patent Application No. 60/544,348, filedFeb. 17, 2004, to Paul SCOPTON and John A. GRIEGO entitled ENDOSCOPICDEVICE AND RELATED METHODS OF USE, the entirety of which is incorporatedherein by reference. This application also claims the benefits ofpriority under 35 U.S.C. §§ 119(e), 120 to U.S. Provisional PatentApplication No. 60/612,781, filed Sep. 27, 2004, to Paul SCOPTON, JohnA. GRIEGO. Stephen J. PERRY, and William SHAW entitled ENDOSCOPICDEVICES AND RELATED METHODS OF USE, the entirety of which isincorporated herein by reference.

DESCRIPTION OF THE INVENTION

1. Field of the Invention

Embodiments of the invention include a medical device including a handleportion, an end effector assembly, an elongate member connecting thehandle portion and the end effector assembly, and one or more treatmentdevices extendable through the elongate member and end effectorassembly. The end effector assembly includes an electrode assemblyconfigured to cauterize tissue. The treatment devices may include anelongate cutting member with a safety tip. The treatment devices mayinclude a multi-lumen catheter with a lumen configured to deliver fluidand another lumen configured to accommodate an injection needle, acutting member, or other therapeutic or diagnostic devices.

2. Background of the Invention

Endoscopic methods are commonly used for diagnosis and/or treatment ofthe gastrointestinal tract. For example, there are several methods oftreating esophageal cancer known as endoscopic mucosal resection.Endoscopic mucosal resection may include snaring and then excisingsessile adenomas (i.e., tumors attached to a bodily surface) in theesophageal tract. If the adenoma is flat against the esophageal tract,thus making it difficult to snare and excise, one of several methods maybe used to raise the flat adenoma so that it may be snared and excised.One method includes using forceps to raise the flat adenoma. Anothermethod includes using a vacuum to raise the flat adenoma. A furthermethod includes injecting saline into the submucosa so as to raise theflat adenoma. If, during saline injection, it is determined that theadenoma is attached to multiple esophageal tissue layers, additionalmethods may be required to remove the adenoma. Once the adenoma isexcised, bleeding into the esophageal tract may result from the portionof the esophageal tissue from which the adenoma was removed.

These, and other medical procedures (e.g., staining, marking, andidentifying tissue), may involve making an incision in body tissue andcontrolling any consequent bleeding. When performing these procedures,it may be desirable to minimize both tissue trauma during incision andthe time required to stop internal bleeding. Minimally invasive or leastinvasive surgical techniques, such as laparoscopic, endoscopic, orarthoroscopic techniques, are sometimes used because body tissue isusually traumatized less by those techniques than by more invasiveconventional techniques. Electrosurgical methodologies, sometimes usedin conjunction with the minimally or least invasive techniques, allowthe making of an incision and the stopping or stemming of bleeding withless attendant tissue trauma and greater control than do conventionalmodalities.

Several medical instruments may be used to make an incision and stemconsequent bleeding. In accordance with one modality that is suited forapplication in the gastrointestinal tract, a physician initiallypositions a flexible endoscope in the patient with its distal endproximate to an incision site, and inserts a device for making anincision through a working port of the endoscope to the incision site.The physician can also insert an irrigator through a working port in theendoscope to clear the area by administering water or saline solution asa precursor to any attempts to make an incision or stop bleeding. Theirrigator can also be used to inject water or saline solution betweentissue layers so as to separate the tissue layers.

If the instrument being used for irrigation is like the Injection GoldProbe™ hemostasis catheter manufactured by Boston ScientificCorporation, the physician can then cauterize a bleeding vessel using adistally positioned hemostat. Such instruments are constructed to beemployed through a working port of an endoscope to seal potentialbleeding sites in the gastrointestinal tract. Alternatively, thephysician can retract the irrigating catheter and insert an elongatedneedle through the endoscope to inject a vaso-constrictor into thevessel to slow hemorrhaging. Then the physician can remove the elongatedneedle and reinsert the hemostat to finish the operation.

Some hemostats use mono-electropolar electrodes in which one electrodemay be carried by a catheter to a site while the other electrode may bean exterior ground plate placed in or on a patient. The above-mentionedGold Probe™ hemostat is an example of a device that supplies a suitablecurrent density and wave form of radio frequency energy to performelectro-coagulation or electro-cauterization. It utilizes a catheterwith a bipolar electrode assembly located on a flexible shaft formed ofa ceramic cylinder having a hemispherical end. The ceramic tip includesa pair of spaced gold spiral electrodes applied to its cylindricalsurface and domed end. RF energy applied to the electrodes produces acurrent through adjacent tissue that heats and cauterizes thehemorrhaging vessel which is contacted by the tip of the catheter. TheInjection Gold Probe™ hemostasis catheter also permits needle injectionwith a single catheter.

The aforementioned methods, while effective, have certain drawbacks. Asphysicians sometimes use different catheters to perform differentfunctions, for example, use one catheter to make an incision and anotherto perform hemostasis or irrigation, the exchange of catheters toprovide different functions extends the time to complete therapy,increases the risk to the patient and also increases patient discomfort.Consequently, physicians have to weigh the time, complexity and benefitsof interchanging single or dual purpose catheters to change treatmentmodalities against whatever disadvantage may result by working with asingle catheter.

U.S. Pat. Nos. 5,336,222, 5,403,311, and 6,325,800 B1, and U.S. PatentApplication No. 2002/0111623 A1, the contents of all of which areincorporated herein, each disclose an integrated catheter assembly forenabling diverse in situ therapies which includes a catheter with anirrigation fluid lumen, a distal tip portion that acts as a hemostat,and a needle for injection therapy.

SUMMARY OF THE INVENTION

In accordance with the invention, an embodiment of the inventionincludes a device for performing therapy on body tissue. The deviceincludes a catheter, an end effector assembly connected to the catheterand configured to cauterize body tissue, an elongate member extendingthrough the catheter and the end effector assembly and configured tomove relative to the catheter and the end effector assembly, and asafety tip on the distal end of the elongate member configured to reducedamage to body tissue.

Another embodiment of the invention includes a device for performingtherapy on body tissue. The device includes a catheter, an end effectorassembly connected to the catheter and configured to cauterize tissue,wherein a port extends through the catheter and the end effectorassembly, a needle extending through at least a portion of the port andconfigured to move relative to the port, and a cutter extending throughat least a portion of the port and configured to move relative to theport.

A further embodiment of the invention includes a device for performingtherapy on body tissue. A device includes a catheter, an end effectorassembly connected to the catheter and configured to cauterize tissue,and a medical device extending through the catheter and the end effectorassembly and configured to move relative to the catheter and the endeffector assembly. The medical device is configured to deliver fluid,cut tissue, and cauterize tissue.

Various embodiments of the invention may have any or all of thefollowing features. At least one of the elongate member and the safetytip may be configured to conduct electricity. At least one of theelongate member and the safety tip may be configured to cauterize bodytissue. The end effector assembly may be configured to receive at leasta portion of the safety tip. The elongate member may be configured tocut tissue. The device may include a port extending through the elongatemember and the safety tip. The port may be configured to deliver fluid.The port may be configured to remove fluid. The elongate member may be awire. The tissue cutting device may extend through the needle and may beconfigured to move relative to the needle. The device may include asafety tip connected to the end effector assembly and configured toreduce damage to body tissue. The device may include a second portextending through the end effector assembly. The port may be defined bya second catheter axially movable relative to the catheter and endeffector assembly. The second catheter may define a second port. Themedical device may be configured to conduct electricity. The medicaldevice may define a first port and a second port. The first port mayinclude a needle and the second port may be configured to deliver fluid.The needle may include a cutting mechanism extendable therefrom. Thedevice may include a second medical device extending through thecatheter and the end effector assembly and configured to move relativeto the catheter and the end effector assembly.

Still another embodiment of the invention includes a method ofperforming therapy on body tissue. The method includes introducing acatheter into a gastrointestinal tract of a patient, advancing a distalend effector assembly of the catheter to tissue to be treated, the endeffector assembly including an electrode assembly configured tocauterize tissue, and advancing a medical device through a lumen of thecatheter, the medical device capable of delivering fluid, cuttingtissue, and cauterizing tissue.

Various embodiments of the invention may have any or all of thefollowing features. The medical device may be configured to conductelectricity. The method may include providing electricity to theelectrode assembly. The method may include providing electricity to themedical device. The medical device may include a port. The method mayinclude introducing fluid into the gastrointestinal tract via the port.The medical device may include a needle. The method may includeadvancing the needle into the tissue to be treated. A safety tip may beconnected to the end effector assembly and configured to reduce damageto body tissue. The method may include moving the safety tip relative tothe end effector assembly. The method may include advancing a secondmedical device through a second lumen of the catheter. The method mayinclude moving the second medical device relative to the end effectorassembly.

A still further embodiment of the invention includes a device forperforming therapy on body tissue. The device may include a catheter, anelectrically conductive elongate member extending through the catheterand configured to move relative to the catheter, and a safety tip on thedistal end of the elongate member configured to reduce damage to bodytissue.

Various embodiments of the invention may have any or all of thefollowing features. The safety tip may be configured to conductelectricity. The elongate member may be configured cut tissue. Thesafety tip may be configured to cauterize tissue. The catheter may bemade of an insulating material. A distal end of the catheter may beconfigured to conduct electricity. A distal end of the catheter may beconfigured to cauterize tissue. The safety tip may be made of aninsulating material. A channel may extend through at least one of thecatheter, the elongate member, and the safety tip. The channel mayconfigured to deliver fluid. The channel may be configured to removefluid. A plurality of channels may extend through the safety tip. Asheath may be disposed between the elongate member and the catheter. Thesheath may be moveable relative to both the elongate member and thecatheter.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

FIG. 1A is a perspective view of an endoscopic device according to anembodiment of the invention.

FIG. 1B is a perspective view of the endoscopic device of FIG. 1A in analternate configuration.

FIG. 2A is a perspective view of an endoscopic device according toanother embodiment of the invention.

FIG. 2B is a perspective view of the endoscopic device of FIG. 2A in analternate configuration.

FIG. 3 is a perspective view of an endoscopic device according to afurther embodiment of the invention.

FIG. 4 is a perspective view of an endoscopic device according to yetanother embodiment of the invention.

FIG. 5 is a perspective view of an endoscopic device according to a yetfurther embodiment of the invention.

FIG. 6 is a schematic view of the endoscopic device of FIG. 1A.

FIGS. 7A-7Q are schematic views of various safety tips according tovarious embodiments of the invention.

FIG. 8 is a schematic view of an endoscopic device according to stillanother embodiment of the invention.

FIGS. 9A-9C are schematic views of an endoscopic device according to astill further embodiment of the invention.

FIG. 10A is a schematic view of an endoscopic device according to afurther embodiment of the invention.

FIG. 10B is a cross-sectional view of the endoscopic device of FIG. 10Aalong line X-X of FIG. 10A.

FIGS. 11A-11B are schematic views of an endoscopic device according toyet another embodiment of the invention.

FIG. 12A is a schematic view of a method of using the endoscopic deviceof FIG. 1B.

FIG. 12B is a schematic view of a method of using the endoscopic deviceof FIGS. 9A-9C.

FIG. 13 is a schematic view of an endoscopic device according to stillanother embodiment of the invention.

FIGS. 14A-14D are schematic views of an endoscopic device according to astill further embodiment of the invention.

FIGS. 15A-15N are schematic views of various elongate members accordingto various embodiments of the invention.

FIGS. 16A-16F are perspective views of various endoscopic devicesaccording to various embodiments of the invention.

FIG. 17 is a schematic view of an endoscopic device according to anotherembodiment of the invention.

FIG. 18 is a schematic view of an endoscopic device according to afurther embodiment of the invention.

FIG. 19 is a schematic view of an endoscopic device according to yetanother embodiment of the invention.

FIG. 20A is a schematic view of an endoscopic device according to a yetfurther embodiment of the invention.

FIG. 20B is a schematic view of an endoscopic device according to stillanother embodiment of the invention.

FIG. 21 is a schematic view of an endoscopic device according to a stillfurther embodiment of the invention.

FIGS. 22A-22B are schematic views of another embodiment of theinvention.

FIGS. 23A-23B are schematic views of a further embodiment of theinvention.

FIGS. 23C-23D are schematic views of yet another embodiment of theinvention.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the specification andaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the specification and drawings to refer to thesame or like parts.

FIGS. 1A-1B and 6 depict an exemplary embodiment of an endoscopicdevice. The endoscopic device may be used for endoscopic mucosalresection or other endoscopic procedures during which electrocauteryand/or excising is desired. The endoscopic device 1 includes a catheter10 with an end effector assembly 11 mounted on the distal end of thecatheter 10. The catheter 10 is connected to a handle portion 9.Catheter 10 may be comprised of any suitable, elongate member known toone skilled in the art and having sufficient flexibility to traversetortuous anatomy of a patient's gastrointestinal tract. Catheter 10defines a lumen therein. Handle portion 9 similarly may be comprised ofany suitable handle mechanism known to one skilled in the art and havingthe ability to control the operation of the endoscopic device 1 fromoutside of a patient. FIG. 6 depicts handle portion 9 in a general,non-specific form, as a box. However, the depiction of the handleportion in FIG. 6 as a box is exemplary only, as the handle portion 9may be any type of suitable handle known in the art, examples of whichare disclosed in U.S. Pat. Nos. 5,336,222, 5,403,311, 6,602,262 B2,6,325,800 B1, and U.S. Patent Application No. 2002/0111623 A1, theentirety of all of which are incorporated herein by reference.

The end effector assembly 11 may include an electrode assembly 13. Theend effector assembly 11 and any of its components may be controlled byhandle portion 9 that connects to the end effector assembly 11 and itscomponents via the catheter 10. The electrode assembly 13 may be eithera monopolar or bipolar electrode assembly having a body portion 16 withone or more discrete spiral electrodes 14 disposed on the body portion16. As shown in FIGS. 1A-6, 8, 9A-9C, 10A-10B, 11A-11B, 12A-12B, 13,14A-14B, 15A-15N, 16A-16F, 17-19, 20A-20 b, 21, 22A-22B, and 23A-23B thebody portion 16 may be cylindrical, however, the body portion 16 mayhave any desired geometric shape and/or configuration. The electrodeassembly 13 may be connected via electrical leads to a power source, forexample, a radio-frequency (RF) generator. An example of an electrodeassembly, including a spherical distal tip, cylindrical body portion,discrete spiral electrodes, proximally extending shank, and electricalleads is disclosed in U.S. Pat. No. 5,336,222, the entirety of which isincorporated herein by reference. The electrode assembly 13 isconfigured to electro-coagulate tissue that comes into contact with aportion of the electrode assembly 13, for example, the one or morediscrete spiral electrodes 14.

An elongate member 17 having a safety tip 15 may extend within the lumenof the catheter 10. When elongate member 17 is fully retracted withincatheter 10, the safety tip 15 may be disposed on the distal end of theend effector assembly 11. The safety tip 15 is configured to preventperforation of bodily tracts, for example the gastrointestinal tract, byportions of the end effector assembly 11 or elongate member 17.

The distal portion of the end effector assembly 11 is configured toreceive, correspond to, and/or accommodate the proximal portion of thesafety tip 15. For example, the safety tip 15 may have a substantiallycone-shaped proximal portion. Correspondingly, the end effector assembly11, and particularly its body portion 16, may have a substantiallycone-shaped groove configured to receive the cone-shaped portion of thesafety tip 15. The cone-shaped portion of the safety tip 15 and/ordistal edge of the end effector assembly 11 (i.e., outer edge of thecone-shaped groove and/or body portion 16) may be arranged to cut and/ortrap tissue, for example, while the cone-shaped portion of the safetytip 15 is being placed into the cone-shaped groove of the body portion16. In the embodiment shown in FIGS. 1A-1B, the safety tip 15 has asubstantially hemispherical configuration, however, any suitable shapeand/or configuration is also contemplated, for example, round,triangular, oval, etc.

Non-limiting examples of safety tips 15 having various shapes and/orconfigurations are shown in FIGS. 7A-7Q. FIG. 7A depicts safety tip 15having a substantially spherical configuration. Tip 15 in FIG. 7A mayhave any suitable diameter including any one of the following exemplarydiameters: 2.0 mm; 1.85 mm; and 1.79 mm. FIG. 7B depicts safety tip 15having a substantially conical configuration. FIG. 7C depicts safety tip15 having a pyramid-shaped configuration. FIG. 7D depicts safety tip 15having a substantially conical configuration with the apex portion 15 aof the conical-shaped safety tip 15 pointing away from elongate member17, and a rounded configuration on the base portion 15 b of safety tip15 pointed toward and connected to elongate member 17. FIG. 7E depictssafety tip 15 having a pyramid-shaped configuration with the apexportion 15 a of safety tip 15 pointing away from elongate member 17, anda rounded configuration on the base portion 15 b of safety tip 15pointed toward and/or connected to elongate member 17. FIG. 7F depictssafety tip 15 having a rounded configuration on the base portion 15 a ofsafety tip 15 pointing away from elongate member 17, and a substantiallyconical configuration at the portion 15 b of safety tip 15 pointingtowards and connected to elongate member 17. FIG. 7G depicts safety tip15 having a rounded configuration at the portion 15 a of safety tip 15pointing away from elongate member 17, and a pyramid-shapedconfiguration at the portion 15 b of safety tip 15 pointing towards andconnected to elongate member 17. FIG. 7H depicts safety tip 15 having asubstantially teardrop-shaped configuration with safety tip 15 taperingtoward elongate member 17. FIG. 7I depicts safety tip 15 having asubstantially hemispherical configuration. FIG. 7J depicts safety tip 15having a substantially hemispherical configuration at the portion 15 aof safety tip 15 pointing away from elongate member 17, and a roundedconfiguration on the portion 15 b of safety tip 15 pointed toward andconnected to elongate member 17. FIG. 7K depicts safety tip 15 having asubstantially elliptical configuration, with a major longitudinal axis15 x of safety tip 15 being disposed substantially perpendicular toelongate member 17. FIG. 7L depicts safety tip 15 having a substantiallyelliptical configuration, with a major longitudinal axis 15 x of safetytip 15 being disposed substantially parallel to and/or coaxially alignedwith elongate member 17. Tip 15 may rotate about member 17 via anysuitable configuration, for example, a ball and socket assembly or a Tand socket assembly.

FIG. 7M depicts safety tip 15 configured to rotate relative to elongatemember 17, for example, about an axis 15 x substantially perpendicularto elongate member 17. In this example, any suitable connection betweenmember 17 and tip 15 that permits such rotational motion may be used,for example, by connecting member 17 to a stationary portion 15 y, andhaving movable portion 15 w rotate relative to stationary portion 15 y.Such a configuration may reduce friction during cutting of tissue bymember 17.

FIGS. 7N and 7O depict a safety tip 15 in an unexpanded and expandedconfiguration, respectively. Safety tip 15 may be made of an expandablematerial and may be expanded, for example, by placing a hollow interior15 h of safety tip 15 in flow communication with a source of fluid via alumen 17I running through elongate member 17.

FIG. 7P depicts a bipolar safety tip 15 having one or more spirals 15 e.One or more of spirals 15 e may be electrodes and may be connected tothe same power source, or may each be connected to different powersources.

Safety tip 15 may be made out of any suitable material, for example, aconductive material such as stainless steel or a non-conductive such asceramic. An example of a suitable material is Epoxy Tip Bipax Tra-BondBA-FDA2T Lot 4030. Safety tip 15 may be placed on elongate member 17using any method. For example, as shown in FIG. 21, an end 17 k ofelongate member 17 may have a substantially hook-like configuration andsafety tip 15 may be formed around the substantially hook-like portion17 k of elongate member 17, for example, by injection molding or anyother method.

The safety tip 15 is movable relative to the end effector assembly 11and its electrode assembly 13 via elongate member 17. FIG. 1A shows thesafety tip 15 in a retracted configuration, while FIG. 1B shows thesafety tip 15 in an extended configuration. The safety tip 15 may bemovable, for example, to reduce (and possibly prevent) the effect thatthe heat and/or energy from the electrode assembly 13, when activated,has on the safety tip 15. The safety tip 15 may be non-conductive so asto further reduce the effect of the electrode assembly 13 on the safetytip 15.

The safety tip 15 alternatively may be conductive and used as a cauterydevice to coagulate tissue that it may come into contact with. Such aconductive safety tip 15 may be electrically activated in conjunctionwith or separate from the electrode assembly 13, and may have either amonopolar or bipolar configuration. An example of a safety tip 15 havinga bipolar configuration is shown in FIG. 7P. If conductive, the safetytip 15 may be electrically connected to a suitable power source known inthe art (e.g., RF generator) via suitable electrical connections knownin the art (e.g., electrical leads and/or wires or through member 17).The power source may be disposed anywhere on or relative to the device1, for example, at the handle 9 or connected to the handle 9. Anotherexample of a bipolar configuration is shown in FIG. 7Q, where electrodes15 e 1 and 15 e 2 may be electrically isolated from each other byinsulation 115, for example, such that they have opposite polarities.

Safety tip 15 may be movable relative to elongate member 17. Forexample, as shown in FIG. 13, safety tip 15 may be selectably detachablefrom elongate member 17, and may be connected to elongate member 17 viaconnector 15 c in the detached configuration. Safety tip 15 may bedetached from elongate member 17 to allow greater and/or more precisemovement of elongate member 17. Connector 15 c may be a flexibleelongate member, such as a wire, that extends through member 17 and iscontrolled at handle 9. Connector 15 c may move relative to member 17within a lumen of member 17.

Safety tip 15 may have one or more cutting and/or cautery portionsdisposed thereon or relative to it. FIG. 16A depicts a safety tip 15with a blade 70 extending from its distal end. Blade 70 may beselectively extended from and retracted within safety tip 15 and/orelongate member 17, for example, to prevent blade 70 from cutting tissueas safety tip 15 is advanced into a body lumen. In various embodiments,blade 70 may be in the shape of a triangle, cone, or any other shape,may be made of any suitable material, and/or may be configured tocauterize tissue (e.g., by being connected to a source of energy).

FIG. 16B depicts a safety tip 15 with a cautery portion 71 (e.g., awire) disposed on a surface of safety tip 15 and/or offset from port 18.Cautery portion 71 may be configured to cauterize tissue and may beconnected to a source of energy, for example, via a wire disposed insafety tip 15, elongate member 17, and/or another portion of device 1.

FIG. 16C depicts a safety tip 15 with a cautery portion 71 that extendsfrom safety tip 15. In such a configuration, cautery portion 71 mayinclude a portion 71 a extending from a surface of safety tip 15, aportion 71 b that is curved or bent relative to portion 71 a and roughlyfollows the surface of safety tip 15, and a portion 71 c that extendsback towards the surface of safety tip 15. Both ends of cautery portion71 (e.g., portions 71 a, 71 c) may be connected to and/or disposedwithin safety tip 15. Like blade 70, cautery portion 71 may beselectively extended from and retracted within safety tip 15 and/orelongate member 17, for example, to prevent cautery portion 71 fromdamaging tissue as safety tip 15 is advanced into a body lumen. Forexample, FIG. 16B may depict cautery portion 71 in the retractedconfiguration, and FIG. 16C may depict cautery portion 71 in theextended configuration. However, in various embodiments, blade 70 and/orcautery portion 71 may be disposed on any portion of safety tip 15 inany desired configuration. FIG. 16D depicts a safety tip 15 with aplurality of cautery portions 71.

FIG. 16E depicts a safety tip 15 with a needle 72 extending towardcatheter 10. In one example, catheter 10 may define a lumen or spaceconfigured to accommodate needle 72 when safety tip 15 is in a retractedconfiguration with respect to catheter 10. In another example, needle 72may be selectably extended and/or retracted from safety tip 15 (e.g.,needle 72 may be spring-loaded and/or needle 72 may be advanced throughmember 17 and/or safety tip 15, and may deflect backwards into safetytip 15 when needle 72 comes into contact with a distal end 10 a ofcatheter 10). FIG. 16F depicts a device with one needle 72 a, as shownin FIG. 16E, and another needle 72 b disposed on catheter 10 andextending towards safety tip 15. Needles 72 a, 72 b may be selectablyextended and/or retracted into safety tip 15 and catheter 10,respectively, using any suitable configuration, for example by beingspring-loaded. In any such configuration, needles 72 a, 72 b may beconfigured to puncture tissue, but when needles 72 a, 72 b contact eachother, they may be configured to retract into safety tip 15 and catheter10, respectively. Needles 72 a, 72 b may be substantially coaxial andmay be configured, for example, to deliver a cross-linking material(e.g., to treat hemostasis) to body tissue into which needles 72 a, 72 bhave punctured from different directions (e.g., substantially oppositedirections). In various embodiments, needle 72 may have any desiredshape configured to puncture tissue (e.g., needle 72 may be tapered andmay be curved), may be configured to deliver any fluid set forth hereininto any body cavity and/or body tissue, and/or may be connected to afluid source via a lumen extending through any portion of device 1, forexample, safety tip 15, elongate member 17, and/or catheter 10.Moreover, needles 72 may be each be connected to substantially the samefluid source, or needle 72 a maybe connected to a first fluid source,while needle 72 b is connected to a second fluid source different fromthe first fluid source. Furthermore, needles 72 may each be configuredto deliver substantially the same fluid, or needle 72 a may beconfigured to deliver a first fluid while needle 72 b may be configuredto deliver a second fluid different from the first fluid. Additionally,needles 72 may be configured to deliver the fluid or fluids atsubstantially the same time, or needle 72 a may be configured to deliverfluids at a time different from needle 72 b.

The elongate member 17 may be configured to be a cutting wire 17, forexample, to cut away tissue from within the gastrointestinal tract. Thecutting wire 17 may be sufficiently thin and therefore sharp that thecutting wire 17 cuts tissue when brought into contact with and/or movedrelative to the desired tissue. The cutting wire 17 may be electricallyactive (having either a monopolar or bipolar configuration) so as toassist in cutting tissue. If conductive, the cutting wire 17 may beelectrically connected to a suitable power source known in the art(e.g., RF generator) via suitable electrical connections known in theart (e.g., electrical leads and/or wires). The power source may bedisposed anywhere on or relative to the device 1, for example, at orconnected to the handle 9.

Elongate member 17 may have any desired dimensions. For example,elongate member 17 may have any suitable diameter, including diametersof approximately 0.015 inches and approximately 0.01 inches. In anotherexample, elongate member 17 may have any suitable length between thedistal end of catheter 10 and safety tip 15, including lengths ofapproximately 4.00 mm. Elongate member 17 may also be made of anysuitable material. For example, elongate member 17 may be made ofstainless steel.

The elongate member 17 may be eccentrically located and/or configured tobend, for example, with respect to the longitudinal axis of the device1. Such eccentric location and/or bending of the elongate member 17 mayassist various portions of the device 1 (e.g., the elongate member 17and/or safety tip 15) in cutting and/or coagulating tissue.

For example, as shown in FIGS. 9A and 9B, a portion 17 a of elongatemember 17 may be configured to curve when elongate member 17 is extendedfrom catheter 10. Portion 17 a may curve as shown in FIG. 9B because itis made of a material configured to receive and hold a preformed curve,for example, nitinol. Such material that makes up portion 17 a may besubstantially the same as or different from the material that makes upother portions of elongate member 17. As shown in FIG. 9C, however, suchportion 17 a may be selectably curvable and/or rotatable so as to allowthe user to control the direction and extent of curvature of portion 17a. Any suitable mechanism at handle 9 to control the curvature androtational orientation of portion 17 a may be used, for example, a freeswivel type device that allows member 17 to self-orient according to thecurvature of and/or force applied to member 17, or a screw mechanismused to control rotatable endoscopic devices such as snares. An exampleof such a screw mechanism is an internal and distally placed screwmechanism, such as that disclosed in U.S. Pat. No. 6,602,262, theentirety of which is incorporated herein by reference.

Such an elongate member 17 having a curved portion 17 a may bedesirable, for example, to allow a user greater control of a cuttinginstrument (e.g., the elongate member 17) and/or to remove greateramounts of a lesion 53 (see FIGS. 12A-12B) than could otherwise be donewith a straight elongate member 17. Such an advantage is illustrated inFIGS. 12A and 12B, where elongate member 17 having curved portion 17 ain FIG. 12B is configured and positioned to remove a greater volume oflesion 53 than straight elongate member 17 of FIG. 12A.

Elongate member 17 may have any suitable shape and/or configuration, andmay have any number of various components, some examples of which areshown in FIGS. 15A-15N. FIG. 15A depicts an elongate member 17 having abow portion 60 whose ends 60 a, 60 b are connected to elongate member17, and whose central portion 60 c is disposed away from elongate member17. FIG. 15B depicts an elongate member 17 that has a bowed portion 17 boffset from a longitudinal axis 17 x of the rest of the device.

FIG. 15C depicts an elongate member 17 having a slotted portion 61 at anend of member 17 that extends from catheter 10. Slotted portion 61 maybe configured to receive, for example, a blade or other flat and/or thinobject to perform an operation on the body. Such an object may slidewithin slot 61 and connect to the handle 9 by an actuator through member17 and/or catheter 10.

FIG. 15D depicts an elongate member 17 having a hoop-like portion 62defining a hole 62 a. FIG. 15E depicts an elongate member 17 having agroove 63 configured to guide a tool 65 or other object along elongatemember 17. Elongate member 17 may also include a ramp and/or elevatorportion 64 disposed on an end of groove 63 that is configured to deflecta tool 65 or other object away from elongate member 17.

FIGS. 15F and 15G depict an elongate member 17 having a blade-likeconfiguration. For example, elongate member 17 may have one or moreedges 17 z that may be relatively sharp, for example, to be configuredto cut tissue. In cross-section, elongate member 17 may have anysuitable shape or configuration, for example, a substantially triangularconfiguration (e.g., as shown in FIG. 15F), pie-shaped configuration,teardrop-shaped configuration, and/or substantially flat configuration(e.g., as shown in FIG. 15G).

FIG. 15H depicts an elongate member 17 having an end 66 in a floppy orJ-shaped configuration. End 66 may be configured to prevent unintendedperforation of tissue 55 (e.g., the esophagus) by end 66 when elongatemember 17 is advanced into a body cavity 57.

FIG. 15I depicts an elongate member 17 that includes two elongatemembers 17 c, 17 d that are configured to cooperate with each other, forexample, so as to act like a snare configured to surround and severlesions, polyps, or other tissue. Members 17 c, 17 d each may assume apreformed configuration shown in FIG. 15I when members 17 c, 17 d extendfrom catheter 10.

FIG. 15J depicts an elongate member 17 including one or more stiffeningmembers 17 e (e.g., stiffening mandrel or hypotube), for example,configured to assist in maintaining a desired curvature (or lackthereof) of elongate member 17.

FIG. 15K depicts an elongate member 17 including indicators 17 i (e.g.,striations, markers) configured to allow a user to visually ascertainthe position of elongate member 17 relative to other objects, forexample, to ascertain the size of a tissue to be cut and/or to ascertainhow much of elongate member 17 has been extended past the distal end ofcatheter 10. Indicators 17 i may be viewed with an endoscope or anyother suitable visualization method, including fluoroscopy.

FIG. 15L depicts an elongate member 17 configured to provide bipolarcautery, for example, via electrode pairs 17 p and 17 r. Pairs 17 p, 17r may be spiral-shaped and may be connected to a source of bipolarcautery current by any suitable connection means.

FIGS. 15M and 15N depict an elongate member 17 including one or morestops 17 s configured, for example, to constrain movement of elongatemember 17 in a proximal and/or distal direction. For example, stop 17 smay be rigidly connected to elongate member 17 and may be disposedwithin slide area 10 s of catheter 10. Accordingly, stop 17 s isconfigured to move within slide area 10 s, but once stop 17 s comes intocontact with proximal end 10 p or distal 10 d of slide area 10 s, stop17 s prevents elongate member 17 from moving proximally and/or distallyrelative to catheter 10.

Elongate member 17 and safety tip 15 may be independently connected toone or more sources of power, for example, to assist in cutting and/orcauterizing tissue. For example, as shown in FIG. 17, device 1 mayinclude a monopolar elongate member 17 and a bipolar safety tip 15.Member 17 may extend through a distal portion 10 q of a catheter.Monopolar elongate member 17 may be connected to a source of current atits proximal end. Bipolar safety tip 15 may be insulated from monopolarelongate member 17 by insulation 115, and may be connected by one ormore wires 117 to one or more sources of energy, such as RF energy.Wires 117 may each be independently connected to different spiralelectrodes 15 s of safety tip 15. Spirals 15 s may be electricallyinsulated from each other, and may each be configured to cauterizetissue. Wires 117 may be disposed within insulation 110 and all of wires117 and insulation 110 may extend through at least a portion of elongatemember 17. A hole 17 h in elongate member 17 may be configured to allowwires 117 and insulation 110 to extend out of elongate member 17.Insulation 110 may be grounded, for example, at its proximal end.Accordingly, in such a configuration, an electrical system includingbipolar safety tip 15 and wires 117 may be substantially electricallyisolated from another electrical system including monopolar elongatemember 17 via one or more of insulation 110 and insulation 115, suchthat each electrical system may be operated independently of the other.

The elongate member 17 may have one or more endoscopic tools deployedwith and/or on the elongate member 17. The one or more endoscopic toolsmay be disposed within the end effector assembly 11 when the safety tip15 and/or elongate member 17 is in the retracted configuration, forexample, by occupying the space within the end effector assembly 11substantially adjacent to the elongate member 17. For example, ahook-like cutting wire may extend from a side portion of elongate member17. In another example, a snare may be attached to the elongate member17.

The endoscopic device 1, including its catheter 10, end effectorassembly 11, safety tip 15, and/or elongate member 17, may have one ormore ports and/or channels. The port(s) and channel(s) may be configuredto perform any endoscopic function and/or accommodate any endoscopicdevice.

For example, in the embodiment shown in FIGS. 2A and 2B, the safety tip15 and elongate member 17 may have a port 18 in flow communication witha channel 18 a configured to introduce materials (e.g., gas(es),fluid(s), solid(s), or any combination of any of these elements) intothe gastrointestinal tract or any other desired body portion, forexample, between submuscosa tissue layers of the gastrointestinal tractso as to separate the mucosal tissue layer from the muscularis layer.The embodiment therefore may be used in any endoscopic procedure duringwhich electrocautery, excising, and/or injection is desired, without theneed for an exchange of catheters. The channel 18 a may extend throughthe safety tip 15 and member 17 to a fluid or solid source connected toa proximal end of member 17. The port 18 and/or channel 18 a may beconfigured to introduce fluid and/or solids into the gastrointestinaltract when the safety tip 15 is in the extended and/or retractedconfiguration relative to the end effector assembly 11. Some examples ofmaterials (e.g., gas(es), fluid(s), solid(s), or any combination of anyof these elements) that may be introduced using the port 18 and/orchannel 18 a include agents to stain or dye tissue, for example forlesion identification, anticholinergic agents for peristalsisinhibition, sclerotic agents for enhancing electro-coagulation of thetissue, vaso-constrictor drugs, flushing fluids, cross-linking agentsfor treating hemostasis, and/or any other agent, fluid, drug, or solidknown in the art and suitable for an endoscopic procedure. The port 18and/or channel 18 a may also and/or alternatively be configured toremove materials from the gastrointestinal tract or any other desiredbody portion, for example, through the use of suction.

In some embodiments, the port 18 and/or channel 18 a may also beconfigured to accommodate one or more endoscopic tools therethrough,whether or not the safety tip 15 and/or elongate member 17 are in theextended or retracted position relative to the end effector assembly 11and/or electrode assembly 13. Examples of endoscopic tools that may beused in conjunction with this embodiment include a cutting wire, aninjection needle, a needle knife, a snare, or other therapeutic ordiagnostic devices, including any of the exemplary devices set forthherein. The port 18 and/or channel 18 a may be configured to irrigatematerials into and/or aspirate materials from the gastrointestinal tracteven with an endoscopic tool extending therethrough. For example, theport 18 and/or channel 18 a may have a cross-sectional area larger thana cross-sectional area of the endoscopic tool extending therethrough. Inanother example, the port 18 and/or channel 18 a may have across-sectional geometric shape that allows materials to be irrigated toand/or aspirated from the gastrointestinal tract even with theendoscopic tool extending therethrough (e.g., the cross-section of theport 18 is square, while the cross-section of the endoscopic tool isround).

As shown in FIG. 8, the distal end of safety tip 15 may include aplurality of ports 18 a. Each of the plurality of ports 18 may connectto one or more channels 18 a that extend through elongate member 17and/or any other portion of endoscopic device 1. Each of ports 18 may bein fluid communication with the same channel 18 a, or one or more ports18 may be in fluid communication with its own dedicated, respectivechannel 18 a. One or more of the plurality of ports 18, and its channel18 a, may be configured to perform substantially the same function(e.g., remove materials from the gastrointestinal tract) or they mayeach be configured to perform different functions (e.g., introducesolids and/or fluids into the gastrointestinal tract while other ports18 and channels 18 a may be configured to remove materials from thegastrointestinal tract). Ports 18 and corresponding channels 18 a may beused to introduce multiple tools to the treatment site.

Ports 18 and/or channel 18 a may be disposed relative to any componentof device 1 in any configuration. For example, as shown in FIGS. 2A-2B,3, 14A-14D, and 16B-16D, port 18 and/or channel 18 a may be disposedwithin safety tip 15 and elongate member 17, and may be substantiallycoaxial with a longitudinal axis of one or more of safety tip 15,elongate member 17, and catheter 10. In another example, as shown inFIG. 8, ports 18 and corresponding channels 18 a may be disposed withinsafety tip 15, and may be variably offset from a longitudinal axis ofone or more of safety tip 15, elongate member 17, and catheter 10. Asshown in FIGS. 10A and 10B, one or more ports 118 and/or channels 118may be disposed within catheter 10 as opposed to safety tip 15 and/orelongate member 17. Channels 118 may run substantially parallel toelongate member 17 and/or the channel 118 within which elongate member17 is disposed in catheter 10.

A flexible head 15 d may be defined by safety tip 15 and/or may beconnected to safety tip 15, for example, where safety tip 15 meets port18. Flexible head 15 d may be made out of any material, for example, anairtight material configured to reverse or invert upon actuation and maybe configured to accommodate suction and/or a vacuum. In a firstconfiguration, as shown in FIG. 14A, flexible head 15 d may defineand/or be substantially flush with the surface of safety tip 15. In asecond configuration, as shown in FIG. 14B, covering 15 d may invert andextend distally away from catheter 10 and/or the surface of safety tip15. Flexible head 15 d may be extended and/or actuated using any method.In the second configuration, covering 15 d may be configured to create avacuum chamber in conjunction with suction from port 18. Thus, covering15 d may assist in funneling fluid and/or debris from a body cavity intoport 18. In another example, however, as shown in FIG. 14C, edge 54 offlexible head 15 d may be pressed against tissue surface 55 so as impedeairflow into air chamber 56 defined by flexible head 15 d and tissuesurface 55. Suction may then be initiated through port 18 such that airis substantially removed from air chamber 56 and at least a portion offlexible head 15 d is substantially flush with tissue surface 55, forexample, as shown in FIG. 14D.

In another embodiment of a device according to the invention, and shownin FIG. 3, a device 19 includes a safety tip 15′ having a port 20configured to accommodate an endoscopic tool therethrough. In thisembodiment, the safety tip 15′ is fixed to and/or integrally formed withthe end effector assembly 11 and is not connected to an elongate portion17. The port 20 may extend through at least portions of the safety tip15′, the end effector assembly 11 and its electrode assembly 13, and thecatheter 10. One or more endoscopic tools may extend through port 20.Examples of endoscopic tools that may be used in conjunction with thisembodiment include a cutting wire, an injection needle, a needle knife,a snare, or other therapeutic or diagnostic devices, including any ofthe exemplary devices set forth herein.

An example of an endoscopic tool that may be used with the endoscopicdevice 19 having a channel 20 is depicted in FIG. 4. The endoscopic tool30 has an elongate housing 31, such as a catheter, that may have one ormore elongate channels extending therethrough. In this embodiment, theelongate housing 31 has two elongate channels 32, 33 that aresubstantially coaxial with each other and the elongate housing 31. Theelongate channels 32, 33 in FIG. 4 have different cross-sectionalshapes, however, they may have the same cross-sectional shape. One ofthe channels 32 may be configured to introduce materials into thegastrointestinal tract, for example, to flush the portion of thegastrointestinal tract where therapy is being performed. The otherchannel 33 may be configured to accommodate an injection needle 34, asnare, or any other endoscopic tool and/or allow the injection needle34, the snare, or other endoscopic tool to move axially relative to theelongate housing 31.

The injection needle 34 may have an outer sheath covering 35 disposedaround and axially movable relative to the injection needle 34. In theposition shown in FIG. 4, the distal end of sheath 35 is proximal to asharpened portion 36 of the needle 34. The injection needle 34 may beconfigured to penetrate tissue, for example, by having a sharpenedportion 36 that is angled relative to the longitudinal axis of theinjection needle 34. The needle 34 may also be used to introducematerials into the gastrointestinal tract or any other body portionthrough its lumen 37. The needle 34 may be electrically active (i.e.,monopolar or bipolar) so as to penetrate tissue and/or assist inpenetrating tissue.

The sheath 35, or any other endoscopic tool, sheath, or lumen on or usedin conjunction with endoscopic tool 30, may be electrically active(i.e., monopolar or bipolar). The sheath 35 may be configured to createa vacuum and/or introduce materials into the gastrointestinal tractand/or tissue defining the gastrointestinal tract. The creation of thevacuum and/or introduction of materials may be implemented around anendoscopic tool extending through the sheath 35, or separate from theendoscopic tool as the endoscopic tool does not extend through thesheath 35. For example, the sheath 35 may be configured to create avacuum so as to position tissue (e.g., place tissue in the sheath 35),and then the needle 34 may be advanced through the sheath 35 and intothe tissue.

Some or all of the electrode assembly 13, the safety tip 15′, theelongate housing 31, the injection needle 34, the outer covering 35, andany other portion of device 19 may be configured to move axially orotherwise relative to each other, for example, by being made of eitherdifferent or same materials suitable for such movement and/or havingdimensions that allow the aforementioned portions to move relative toeach other. Thus, the injection needle 34 may be retracted inside theouter covering 35, the outer covering 35 may be retracted inside port 33of the outer housing 31, and/or outer housing 31 may be retractableinside safety tip 15′, electrode assembly 13, catheter 10, and/or anyother portion of the device 1.

FIG. 5 depicts an embodiment of a device 19 substantially similar to thedevice depicted in FIG. 4, with the added feature of a cutting tool 40.The cutting tool 40 may be configured to cut tissue, for example, byhaving a sharp edge 41. The cutting tool 40 (or knife) may beelectrically active (i.e., monopolar or bipolar) so as to cut tissueand/or assist in cutting tissue, and may traverse the lumen 37 of theneedle 34. When extended past the sharpened portion 36 of the needle 34,at least a portion of the cutting tool 40 may bend or be bent so that atleast a portion of the cutting tool 40 is no longer substantiallycoaxial with the lumen 37 and/or needle 34. The cutting tool 40 may bemade of a shape memory alloy or other similar material that causes thecutting tool 40 to bend once it is no longer axially constrained. Thedevice 19, end effector assembly 11, electrode assembly 13, safety tip15′, and/or outer housing 31 may include an additional parallel passageto house a tool configured to allow the user to control the bending ofthe cutting tool 40. Instead of using lumen 37 of needle 34, theadditional parallel passage may be used to advance the cutting tool 40into the gastrointestinal tract, independent of the endoscopic tool 30,so as to permit crossing the cutting tool 40 with at least portions ofthe endoscopic tool 30, for example, the injection needle 34, and topermit simultaneous use of cutting tool 40 and injection needle 34.

As shown in FIGS. 22A and 22B, a portion 10 a of catheter 10 may beconfigured to curve when the portion 10 a of catheter 10 is extended outof a lumen 51 of endoscope 50 within which catheter 10 may be disposed.Portion 10 a may be made of a material configured to receive and retaina curvature, and may be made of substantially the same or differentmaterial as other portions of catheter 10. Such curving of the catheter10 may assist various portions of the device 1 (e.g., the elongatemember 17 and/or safety tip 15) in cutting and/or coagulating tissue.

As shown in FIGS. 11A and 11B, a sheath 52 may be coaxial with, and/ordisposed over, and movable relative to at least a portion of catheter10. Sheath 52 may be configured in that in a first configuration asshown in FIG. 11A, when sheath 52 is not disposed over at least a distalportion of catheter 10, catheter 10 may have a substantially straightconfiguration. However, when sheath 52 is in a second configuration asshown in FIG. 11B and disposed over at least a distal portion ofcatheter 10, catheter 10 may have a curved configuration. The portion10A of catheter 10 that is curved when sheath 52 is deployed over it maybe made of the same material or a different material (e.g., a softermaterial) than the rest of catheter 10. In various embodiments, however,the reverse also may be true. Thus, catheter 10, when unsheathed, may bemade of a material that retains a preformed curve, however, when sheath52 is advanced over catheter 10, catheter 10 may assume a substantiallystraight configuration.

Device 1, and more specifically end effector assembly 11 and its variouscomponents, as well as the catheter leading to the assembly 11, may havea variety of configurations. For example, as shown in FIG. 18, device 1may include a non-electrically conductive safety tip 15 having asubstantially spherical configuration, an elongate member 17 connectedto an electrical power source and configured to cut tissue, and amonopolar electrode assembly 13 on the distal end of catheter 10.Monopolar electrode assembly 13 may have an outer diameter of about 2.6mm, safety tip 15 may have a diameter of about 2.0 mm, and elongatemember 17 may have a diameter of about 0.01 inches. Catheter 10 mayinclude one or more ports 118 in flow communication with a respectivechannel 118 a. One port 118 and channel 118 a may be configured toaccommodate elongate member 17 and allow elongate member 17 to movelongitudinally relative to catheter 10. Another port 118 and channel 118a may be configured to irrigate fluid and/or aspirate debristherethrough. Another port 118 and channel 118 a may be configured toaccommodate a wire therethrough, for example, to connect monopolarelectrode assembly 13 to a source of energy.

In another example, as shown in FIG. 19, device 1 may include annon-electrically conductive safety tip 15 having a substantiallyspherical configuration, an elongate member 17 connected to anelectrical power source and configured to cut tissue, and a bipolarelectrode assembly 13 with one or more spiral electrodes 14 disposed onthe distal end of catheter 10. Bipolar electrode assembly 13 may have anouter diameter of about 2.3 mm, safety tip 15 may have a diameter ofabout 1.6 mm, and elongate member 17 may have a diameter of about 0.02inches. Elongate member 17 may be disposed in a channel 118 a ofcatheter 10, and may exit a distal end of catheter 10 through port 118which is flow communication with channel 118 a. Port 118 and channel 118a may be configured to allow elongate member 17 to move longitudinallyrelative to catheter 10.

In a further example, as shown in FIGS. 20A and 20B, device 1 mayinclude a cautery tip 15 connected to a source of electricity and anelongate member 17 connected to an electrical power source andconfigured to cut tissue. FIG. 20A depicts a device 1 with no electrodeassembly or cautery portion on the distal end of catheter 10. FIG. 20Bdepicts a device 1 with an electrode assembly 13 (e.g., cautery portion)on the distal end of catheter 10. Cautery tip 15 may be insulated fromelongate member 17 by insulation 115. Safety tip 15 (e.g., cautery tip)may have a diameter of about 2.0 mm and elongate member 17 may have adiameter of about 0.025 inches. Catheter 10 may include one or moreports 118 in flow communication with their respective channel 118 a. Oneport 118 and channel 118 a may be configured to accommodate elongatemember 17 and allow elongate member 17 to move longitudinally relativeto catheter 10. Another port 118 and channel 118 a may be configured toirrigate fluid and/or aspirate debris therethrough. Another port 118 andchannel 118 a may be configured to accommodate a wire therethrough, forexample, to connect monopolar electrode assembly 13 to a source ofenergy. Elongate member 17 may include a lumen within which a wire 117is disposed therethrough. Wire 117 may be electrically connected to bothcautery tip 15 and a source of energy.

In various embodiments, device 1 may be configured to be advancedthrough a working channel of an endoscope. For example, the workingchannel may have a diameter of about 2.8 mm.

FIGS. 23A and 23B depict a device 1 including a cautery tip 15, anelongate member 17, a catheter 10, and a monopolar electrode assembly 13disposed on a distal end of catheter 10. Cautery tip 15 may be hollow(e.g., to assist in dissipating heat) and may include one or more ports18. Ports 18 may be configured to expel a fluid and/or gaseous mediumout of hollow cautery tip 15 h, and/or may be configured to remove afluid and/or gaseous medium from the outside of device 1. Cautery tip 15may be monopolar or bipolar. Elongate member 17 may be configured to cuttissue and/or may be connected to a source of energy. Device 1 mayinclude a sheath 80. Sheath 80 may be made of any suitablenon-conductive material and may be configured to move longitudinallyrelative to cautery tip 15 and/or elongate member 17. In a firstconfiguration, as shown in FIG. 23B, sheath 80 may be configured tosubstantially cover cautery tip 15 and elongate member 17. For example,sheath 80 may be configured to cover all of cautery tip 15 and elongatemember 17 except a distalmost portion of cautery tip 15. For example,sheath 80 may have a tip portion 80 a configured to cover a proximal andsurrounding portion of cautery tip 15, for example, by having a diameterlarger than cautery tip 15. Sheath 80 may also have an elongate portion80 b configured cover at least a portion of elongate member 17. Sheath80 may further have a transition portion 80 c configured to cover aproximal portion of cautery tip 15 and a distal portion of elongatemember 17. Transition portion 80 c may conform to a shape of theproximal portion of cautery tip 15, for example, by having asubstantially hemispherical shape. In a second configuration, as shownin FIG. 23A, sheath 80 may be configured to be substantially retractedinto catheter 10, for example, such that a distal end of sheath 80 doesnot extend past a distal end of catheter 10. In such a configuration,cautery tip 15 and/or elongate member 17 may be substantially exposed.In another example, as shown in FIGS. 23C and 23D, sheath 180 may bemade of any suitable expandable material. Accordingly, in a firstconfiguration, sheath 180 may cover a proximal and surrounding portionof cautery tip 15, for example, by stretching until sheath 180 hassubstantially the same as or slightly larger than a diameter of cauterytip 15. Moreover, in a second configuration, sheath 180 may besubstantially retracted into the catheter 10, and may have a diameter,at least along its distal portion, that is smaller than the largestdiameter of cautery tip 15, but larger than the diameter of elongatemember 17. Sheath 80, 180 may be connected to an actuator 81 (e.g., apull wire) configured to move sheath 80, 180 longitudinally between thefirst configuration and second configuration. For example, if actuator81 is in the advanced position as shown in FIGS. 23B and 23D, thensheath 80, 180 is covering cautery tip 15 and elongate member 17. Inanother example, if actuator 81 is in the retracted position, as shownin FIGS. 23A and 23C, then cautery tip 15 and elongate member 17 areexposed. A distal portion of catheter 10 may include a lumen configuredto accommodate sheath 80.

In a method of using the endoscopic device 1, 19, the endoscopic device1, 19 is advanced into a gastrointestinal tract, for example, theesophagus. The endoscopic device 1, 19 may be advanced into thegastrointestinal tract via a working port of an endoscope, or any othermethod known in the art. Once the endoscopic device 1, 19 and/or the endeffector assembly 11 is placed at the desired portion of thegastrointestinal tract, the end effector assembly 11 or portions of theend effector assembly 11 may be actuated via a handle 9.

The electrode assembly 13 may be placed against a tissue section of thegastrointestinal tract, and then electrically activated so as toelectro-coagulate the desired tissue section. Similarly, the safety tip15, 15′ (if conductive) may be placed against a tissue section of thegastrointestinal tract, and then electrically activated so as toelectro-coagulate the desired tissue section. Such electro-coagulationmay be desirable, for example, to reduce or prevent bleeding from thedesired tissue section.

The elongate member 17 of the device 1 may be extended and then movedrelative to a portion of the gastrointestinal tract, for example, anadenoma, so as to cut the adenoma from the gastrointestinal tract. Theelongate portion 17 may be electrically activated so as to aid in thecutting of tissue.

Materials (e.g., gas(es), fluid(s), solid(s), or any combination of anyof these elements) may be introduced into and/or aspirated from thegastrointestinal tract via one or more of the port 18, port 20, port 32,and lumen 37, for example, to flush out a portion of thegastrointestinal tract, determine whether an adenoma is attached tomultiple esophageal layers, and/or perform any other therapeutic ordiagnostic operation involving injection. The materials may beintroduced into and/or aspirated from the gastrointestinal tract via oneor more of the port 18, port 20, port 32, and lumen 37 while one or moreof the elongate member 17, outer housing 31, outer jacket 35, andinjection needle 34 is in either the extended or retractedconfiguration.

An endoscopic tool 30 may be advanced into the gastrointestinal tractvia port 20. An injection needle 34 may be advanced past an outerhousing 31 and/or an outer jacket 35 and into the gastrointestinal tractand/or a wall of the gastrointestinal tract, for example, to deliverdrugs or any other substance into the wall of the gastrointestinaltract. The injection needle 34 may also be used to cut tissue from thegastrointestinal tract, for example, by placing the injection needle 34in contact with the tissue and moving the injection needle 34 relativeto the tissue.

A cutting tool 40 may be advanced into the gastrointestinal tract viaport 20, port 33 of outer housing 31, lumen 37 of injection needle 34,and/or a passage parallel to any of the aforementioned ports and/orlumens described herein. The cutting tool 40 may then be actuated to cuttissue from a portion of the gastrointestinal tract, for example, byplacing the cutting tool 40 in contact with the tissue and moving thecutting tool 40 relative to the tissue. The cutting tool 40 may beelectrically activated so as to aid in the cutting of the tissue.

One or more of the port 18, port 20, port 32, lumen 37, or any otherlumen of the device 1 may be configured to trap and/or capture tissue.For example, tissue may be trapped in port 37 as the needle 34 isadvanced into the tissue. In another example, after tissue has beenexcised from the walls of the gastrointestinal tract, a vacuum may becreated in port 20 so as to capture the tissue so that it may be removedfrom the gastrointestinal tract for further analysis.

In various embodiments, any of the aforementioned methods may beperformed while one or more of the safety tip 15, elongate member 17,endoscopic tool 30, outer housing 31, outer jacket 35, injection needle34, and cutting tool 40 is in either the extended or retractedconfiguration.

In various embodiments, any of the aforementioned aspects of any of theembodiments may be combined with any other aspect of any of the otherembodiments. For example, an endoscopic device may include the cuttingwire 17 and the cutting tool 40. Furthermore, aspects of the embodimentsmay be removed from the endoscopic devices. For example, the outerjacket 35 may be removed from the embodiments set forth in FIGS. 4-5.

The geometric and spatial configurations of various aspects of theembodiments depicted herein are exemplary only and may be rearranged asdesired. For example, aspects of the devices do not have to be coaxialwith each other. In another example, the electrode assembly need not beadjacent to the safety tip. In a further example, aspects of theinvention may have geometric cross-sections of any desired shape andsize.

The devices and methods set forth above may be used in any medical ornon-medical procedure. For example, while the devices and methods setforth above are disclosed as being used in treating the gastrointestinaltract, they may also be used to treat any other suitable body lumen ororgan.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. A device for performing therapy on body tissue, comprising: acatheter; an end effector assembly connected to the catheter andconfigured to cauterize body tissue; an elongate member extendingthrough the catheter and the end effector assembly and configured tomove relative to the catheter and the end effector assembly; and asafety tip on the distal end of the elongate member configured to reducedamage to body tissue, wherein the elongate member includes a bowedportion, wherein the elongate member and the safety tip define a commonlongitudinal axis, and wherein the bowed portion of the elongate memberis offset from the longitudinal axis when the safety tip is positionedon the longitudinal axis, and wherein a distal face of the end effectorassembly defines a groove that receives a proximal portion of the safetytip and is not capable of receiving a distal portion of the safety tip.2. The device of claim 1, wherein at least one of the elongate memberand the safety tip is configured to conduct electricity.
 3. The deviceof claim 1, wherein at least one of the elongate member and the safetytip is configured to cauterize body tissue.
 4. The device of claim 1,wherein the elongate member is configured to cut tissue.
 5. The deviceof claim 1, further comprising a channel extending through the elongatemember and the safety tip.
 6. The device of claim 5, wherein the channelis configured to deliver fluid.
 7. The device of claim 5, wherein thechannel is configured to remove fluid.
 8. The device of claim 5, whereinthe safety tip includes a port in fluid communication with the channel.9. The device of claim 1, wherein the elongate member is a wire.
 10. Thedevice of claim 1, wherein the end effector assembly includes aplurality of electrodes.
 11. The device of claim 10, wherein theplurality of electrodes include a plurality of spiral electrodes. 12.The device of claim 1, wherein the safety tip is configured to moverelative to the end effector assembly.
 13. The device of claim 1,wherein the safety tip includes a portion having a substantiallyhemispherical configuration.
 14. The device of claim 1, wherein thesafety tip includes a portion having a substantially roundedconfiguration.
 15. A device for performing therapy on body tissue,comprising: a catheter; an electrically conductive elongate memberextending through the catheter and configured to move relative to thecatheter; and a safety tip on the distal end of the elongate memberconfigured to reduce damage to body tissue, wherein the elongate memberincludes a bowed portion, wherein the elongate member and the safety tipdefine a common longitudinal axis, and wherein the bowed portion of theelongate member is offset from the longitudinal axis when the safety tipis positioned on the longitudinal axis, and wherein a distal face of theend effector assembly defines a groove that receives a proximal portionof the safety tip and is not capable of receiving a distal portion ofthe safety tip.
 16. The device of claim 15, wherein the safety tip isconfigured to conduct electricity.
 17. The device of claim 15, whereinthe elongate member is configured cut tissue.
 18. The device of claim15, wherein the safety tip is configured to cauterize tissue.
 19. Thedevice of claim 15, wherein the catheter is made of an insulatingmaterial.
 20. The device of claim 15, wherein a distal end of thecatheter is configured to conduct electricity.
 21. The device of claim15, wherein a distal end of the catheter is configured to cauterizetissue.
 22. The device of claim 21, wherein the distal end includes aplurality of electrodes.
 23. The device of claim 22, wherein theplurality of electrodes include a plurality of spiral electrodes. 24.The device of claim 15, wherein the safety tip is made of an insulatingmaterial.
 25. The device of claim 15, further comprising a channelextending through at least one of the catheter, the elongate member, andthe safety tip.
 26. The device of claim 25, wherein the channel isconfigured to deliver fluid.
 27. The device of claim 25, wherein thechannel is configured to remove fluid.
 28. The device of claim 25,wherein the safety tip includes a port in fluid communication with thechannel.
 29. The device of claim 15, further comprising a plurality ofchannels extending through the safety tip.
 30. The device of claim 15,further comprising a sheath disposed between the elongate member and thecatheter, wherein the sheath is moveable relative to both the elongatemember and the catheter.
 31. The device of claim 15, wherein the safetytip is configured to move relative to the catheter.
 32. The device ofclaim 15, wherein the safety tip includes a portion having asubstantially hemispherical configuration.
 33. The device of claim 15,wherein the safety tip includes a portion having a substantially roundedconfiguration.